You have matched to 4 trials

Guest Profile:  No profile selected

Why register? Save your profile, save trials, and enter treatment history for more accurate matching.
1

Evexomostat, Hormone Therapy, and Targeted Therapy for Women with Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation and High <span class="highlight">Blood</span> <span class="highlight">Sugar</span>

Phase 1b/2 Study of the Safety and Efficacy of Evexomostat Plus Alpelisib and Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia With Advanced Breast Cancer and a PIK3CA Mutation Following Endocrine Therapy and a CDK4/6 Inhibitor

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of evexomostat (SDX-7320), an experimental polymer drug conjugate, with fulvestrant (Faslodex®) hormone therapy and alpelisib (Piqray®) PI3K inhibitor.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation who have high <span class="highlight">blood</span> <span class="highlight">sugar.</span> You must have received hormone therapy and a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) is an experimental polymer drug conjugate (PDC), which is similar to an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) releases fumagillol, a type of targeted therapy called a MetAP2 inhibitor. Blocking MetAP2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05455619' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.amelia1.com/' target='_blank'>SynDevRx: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/lead-compound-sdx-7320/' target='_blank'>SynDevRx Drug Information Page: Evexomostat (SDX-7320)</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/science/polymer-drug-conjugation/' target='_blank'>SynDevRx: Polymer Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>
1

Evexomostat, Hormone Therapy, and Targeted Therapy for Women with Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation and High <span class="highlight">Blood</span> <span class="highlight">Sugar</span>

Phase 1b/2 Study of the Safety and Efficacy of Evexomostat Plus Alpelisib and Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia With Advanced Breast Cancer and a PIK3CA Mutation Following Endocrine Therapy and a CDK4/6 Inhibitor
Icon

Nearest Location:
383 miles
Hoag Memorial Hospital Presbyterian
Newport, CA

Icon

Visits:
Number of visits unavailable

Icon

ClinicalTrials.gov: NCT05455619

Icon

Phase I-II

2

Targeted Therapy and Chemotherapy for Advanced Triple Negative or Metaplastic HER2 Negative Breast Cancer

Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of alpelisib (Piqray®) PI3K inhibitor, L-NMMA experimental iNOS inhibitor, and nab-paclitaxel (Abraxane®) chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or metaplastic HER2 negative (HER2-) breast cancer. You must not have received treatment with everolimus (Afinitor®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">L-NMMA, by IV, 2 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Aspirin, by mouth, daily</li> <li class="seamTextUnorderedListItem">Amlodipine, by mouth, daily, 1 week on, 2 weeks off</li> <li class="seamTextUnorderedListItem">Metformin, daily</li> <li class="seamTextUnorderedListItem">Cetirizine, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">L-NMMA is an experimental targeted therapy called a iNOS inhibitor which may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Aspirin and amlodipine help prevent deep venous thrombosis <span class="highlight">(blood</span> clots) and hypertension (high <span class="highlight">blood</span> pressure).</li> <li class="seamTextUnorderedListItem">Metformin helps prevent hyperglycemia (high <span class="highlight">blood</span> <span class="highlight">sugar).</li></span> <li class="seamTextUnorderedListItem">Cetirizine is an anti-histamine that helps prevents allergic reactions to alpelisib (Piqray®).</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05660083' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancer.org: Nab-paclitaxel (Abraxane®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-015-0527-x' target='_blank'>Journal Article: iNOS Inhibition for Triple Negative Breast Cancer</a> </li></ul>
2

Targeted Therapy and Chemotherapy for Advanced Triple Negative or Metaplastic HER2 Negative Breast Cancer

Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)
Icon

Nearest Location:
1644 miles
Houston Methodist Neal Cancer Center
Houston, TX

Icon

Visits:
2 visits every 3 weeks

Icon

ClinicalTrials.gov: NCT05660083

Icon

Phase II

3

Preventing High <span class="highlight">Blood</span> <span class="highlight">Sugar</span> in People with Metastatic ER+, HER2- Breast Cancer with a PIK3CA Mutation

Targeting Insulin Feedback to Enhance Alpelisib (TIFA): A Phase 2 Randomized Control Trial in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer

Purpose: To determine if a ketogenic or low carbohydrate diet with canagliflozin (Invokana®), a high <span class="highlight">blood</span> pressure drug, or canagliflozin (Invokana®) alone can prevent high <span class="highlight">blood</span> <span class="highlight">sugar.</span>

Who is this for?: Post-menopausal women and men with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation who have not received chemotherapy or more than 1 line of hormone therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ketogenic diet</li> <li class="seamTextUnorderedListItem">Canagliflozin (Invokana®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Low carbohydrate diet</li> <li class="seamTextUnorderedListItem">Canagliflozin (Invokana®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Canagliflozin (Invokana®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The ketogenic diet consists of low carbohydrates and high fat.</li> <li class="seamTextUnorderedListItem">Canagliflozin (Invokana®) is a drug approved for treating high <span class="highlight">blood</span> <span class="highlight">sugar</span> for people with type 2 diabetes. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, which allows cancer cells to grow. PI3K inhibitors block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05090358' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://osher.ucsf.edu/patient-care/integrative-medicine-resources/cancer-and-nutrition/faq/low-carbohydrate-diet' target='_blank'>UCSF Osher Center for Integrative Health: Low Carbohydrate Diet and Ketogenic Diet</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healthline.com/nutrition/low-carb-vs-keto' target='_blank'>Healthline: Low Carbohydrate Diet and Ketogenic Diet</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.invokana.com/' target='_blank'>Janssen Drug Information Page: Canagliflozin (Invokana®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>
3

Preventing High <span class="highlight">Blood</span> <span class="highlight">Sugar</span> in People with Metastatic ER+, HER2- Breast Cancer with a PIK3CA Mutation

Targeting Insulin Feedback to Enhance Alpelisib (TIFA): A Phase 2 Randomized Control Trial in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer
Icon

Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

Icon

Visits:
At least 1 visit per month

Icon

ClinicalTrials.gov: NCT05090358

Icon

Phase II

4

Evexomostat and Chemotherapy for People with Advanced Triple Negative Breast Cancer and High <span class="highlight">Blood</span> <span class="highlight">Sugar</span> or High BMI

Phase 2 Randomized Control Trial of Evexomostat (SDX-7320) in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of eribulin (Halaven®) chemotherapy with or without evexomostat (SDX-7320), an experimental polymer drug conjugate.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who have high <span class="highlight">blood</span> <span class="highlight">sugar</span> or a BMI of at least 30 kg/m^2. You must have received chemotherapy and must not have received more than 2 lines of therapy for advanced or metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320), by injection, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo for evexomostat (SDX-7320)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) is an experimental polymer drug conjugate (PDC), which is similar to an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) releases fumagillol, a type of targeted therapy called a MetAP2 inhibitor. Blocking MetAP2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05570253' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='www.aretha1.com' target='_blank'>SynDevRx: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/lead-compound-sdx-7320/' target='_blank'>SynDevRx Drug Information Page: Evexomostat (SDX-7320)</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/science/polymer-drug-conjugation/' target='_blank'>SynDevRx: Polymer Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li></ul>
4

Evexomostat and Chemotherapy for People with Advanced Triple Negative Breast Cancer and High <span class="highlight">Blood</span> <span class="highlight">Sugar</span> or High BMI

Phase 2 Randomized Control Trial of Evexomostat (SDX-7320) in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study
Icon

Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, NJ

Icon

Visits:
1 visit every 1-2 weeks

Icon

ClinicalTrials.gov: NCT05570253

Icon

Phase II